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PolarityBio Gets Breakthrough Status for SkinTE

[ Price : $8.95]

FDA grants PolarityBio a breakthrough therapy designation for SkinTE for treating Wagner Grade 1 diabetic foot ulcers.

2024 Device Recalls Up, Drug Recalls Down: Sedgwick

[ Price : $8.95]

The Sedgwick full-year recall report for 2024 shows medical device recalls increasing and drug recalls decreasing.

Becton Dickinson Recalls ChloraPrep Lot

[ Price : $8.95]

Becton Dickinson recalls one lot of ChloraPrep clear 1 mL applicators due to fungal contamination concerns.

Disappointing Data on Supernus Depression Drug

[ Price : $8.95]

Supernus Pharmaceuticals says its Phase 2b study of SPN-820 in adults with treatment-resistant depression did not demonstrate a st...

Expanded Access to TICE BCG Substitute

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FDA approves an ImmunityBIO expanded access program for recombinant BCG to help address a BCG shortage in treating bladder cancer.

What Happens to FDA in a Budget Shutdown?

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Hyman, Phelps & McNamara regulatory and medical device principal expert Richard Lewis uses his experience at FDA during the 2018-2...

AdvaMed Urges HHS Reversal of FDA Staff Cuts

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Advamed president Scott Whitaker writes HHS to urge a reversal of staff cuts at CDRH to avoid a negative impact on patient care.

FDA Refusal to File Wakix sNDA

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FDA refuses to file a Harmony Biosciences Wakix sNDA to treat excessive daytime sleepiness due to idiopathic hypersomnia.

AGs Seek FDA Actions on Counterfeit GLP-1 Drugs

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A bipartisan coalition of 37 state Attorneys General call on FDA to take enforcement actions against online sellers of counterfeit...

Multiple Violations at Jagsonpal Pharmaceuticals

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FDA warns Indias Jagsonpal Pharmaceuticals about CGMP deviations and other violations in its manufacturing of active pharmaceutica...